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Catalog Number PRD-06419 |
Device Problem
Off-Label Use (1494)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Customer admitted to carelessness when preparing reagents and not checking the master lots of the refrigerated and room temperature components, which would be considered off-label use.Hologic technical support (ts) reviewed logs and found no instrument issues.Since this event was considered off package insert, ts was unable to provide review regarding reagent prep.Ts advised customer to discard the remaining of the prepared kits with mismatched master lots, as well as the unused components of these master lots.Customer understood and reported no further issues.As part of eua agreement, fda requires all aptima sars-cov-2 assay questioning results and false results (confirmed or not) complaints to be reported as malfunction mdr.
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Event Description
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Customer reported accidentally mixing sars-cov-2 tma reagents from different lots, which constitutes as off-label use.Customer used assay lot: 315550 (room temperature reagents) with assay lot: 317372 (refrigerated reagents) and ran patient samples on panther instrument sn: (b)(4).The affected worklist, wl (b)(4), had 3 patient samples.Customer admitted the operator did not match the lots like they were supposed to and grabbed random boxes to mix, confirming this was an operator error.The information provided by the customer was insufficient to characterize any sample as a confirmed false result.Customer confirmed that the results were reported, but the lab supervisor decided to not amend results.There were no associated/reported adverse events or patient impact reported.
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Search Alerts/Recalls
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